As the 118th Congress prepares to reauthorize the Pandemic and All-Hazards Preparedness Act (PAHPA) this year — its first reauthorization of the critical legislation since the beginning of the COVID-19 pandemic — policymakers have a lot to consider, and a great responsibility to make sure that the U.S. is fully prepared when the next pandemic hits. Key to this will be ensuring that the U.S. has all the building blocks of an effective public health emergency response at the ready — including effective antibiotics.
Although they often go under-recognized as a resource, antibiotics are foundational to modern medicine and an essential therapeutic tool to protect all Americans from any pandemic — regardless of its nature.
Antibiotics don’t treat viruses, but viral infections such as influenza and COVID-19 weaken immune systems and put patients at an increased risk of deadly secondary bacterial infections. What’s more, overburdened, under-resourced hospitals become fertile ground for the spread of health care-associated infections during a pandemic. In just the first year of the COVID-19 pandemic, the U.S. saw a 15 percent increase in both infections and deaths from drug-resistant bacteria, according to the Centers for Disease Control and Prevention.
But antibiotics aren’t just important tools in a public health emergency; they’re also vital to our country’s national security.
“There are no walls high enough or oceans wide enough to keep out biothreats and protect our communities” the Biden administration warned in October, noting that the risks from a deliberate attack with bioweapons — the weaponization of biological agents, in other words — are expanding. Antibiotics are essential for the treatment of a wide array of biodefense threats, including anthrax and plague, and history has shown that these and other diseases are easily weaponized. And even if an attack isn’t intentional —in the case of an accidental leak of dangerous material, for instance — antibiotics can help avert disaster.
Antibiotics also help protect the military, security forces and civilians in war zones. Combat injuries often require ready access to antibiotics and can be exacerbated when bacteria are resistant to existing antibiotics. There were more than 53,000 wounded in action during the U.S. military conflicts in Iraq and Afghanistan, and a recent study showed that more than a quarter of combat wound infections during those wars were caused by multidrug-resistant bacteria. And the usefulness of antibiotics in war goes beyond battlefield injuries: Military conflict often damages or destroys public health infrastructure in war zones, rendering it unable to meet patient needs and creating an environment in which infectious diseases can thrive.
Unfortunately, when it comes to antibiotics, U.S. preparedness does not meet the magnitude of the threat. Despite the vital need for these lifesaving drugs as part of virtually any pandemic or public health emergency response, the medicines we rely on to treat serious infections are increasingly ineffective against quickly evolving bacteria. Already, nearly 1.3 million people worldwide die each year from antibiotic-resistant infections; the COVID-19 pandemic accelerated this threat.
And the urgently needed new antibiotics that can combat multidrug-resistant bugs are not being developed — in large part because the market for antibiotics is fundamentally broken. The latest data from the World Health Organization shows a stagnant antibiotic pipeline, with fewer than 50 antibiotics in global clinical development. Alarmingly, just a handful of those drugs are targeted against the pathogens that present the most urgent threats, and based on historical data, most will likely never make it to Food and Drug Administration approval.
Why this dearth of urgently needed antibiotic innovation? In short: There is a stark financial disincentive to invest in the development of these drugs. According to a 2022 report from the Biotechnology Innovation Organization, the average annual revenue from an antibiotic’s sale is just $16 million — a figure that pales in comparison to the investment needed to bring such a drug to market.
As a result, major pharmaceutical companies have backed away from antibiotic development, and the biotech companies remaining in the space are struggling to sustain their operations. In 2021, small companies and nonprofit organizations are responsible for nearly 95 percent of the antibiotic candidates in global clinical development, and over the past several years, a number of those startups have already gone belly-up.
This categorical market failure puts us all at risk, and the market is not going to fix itself.
Congress has an opportunity to protect the public today — and help ensure that the U.S. is better prepared for the next pandemic — by including the bipartisan PASTEUR Act in the Pandemic and All-Hazards Preparedness Act reauthorization. The PASTEUR Act, which supports both antibiotic development and stewardship, will help ensure that lifesaving antibiotics are available when Americans need them most.
PASTEUR is designed to provide a carefully targeted lifeline to companies with promising, medically important new antibiotic candidates through an upfront funding commitment that will give small companies and their investors a strong incentive to stay committed to developing these lifesaving drugs. And crucially, PASTEUR only pays for success: The PASTEUR Act will fund contracts only when a company successfully demonstrates that its drug addresses an unmet need and delivers a notable clinical impact. It’s a win-win.
Congress should address the growing threat that antibiotic resistance poses to public health and safety and include PASTEUR in the PAHPA reauthorization. Antibiotics are simply too important to our nation’s health and security to leave this essential bill behind.
David Hyun, M.D., directs The Pew Charitable Trust’s antibiotic resistance project.